Our Corporate QA has been designed to enhance synergies and develop best practices. The Compliance Control status and the Continuous Improvement process is possible thanks to the contribution both from the Head Quarter Team and the Manufacturing Sites Quality Unit Teams.
From an operative point of view the alignment and the sharing of information is guarantee trough daily transversal collaborations of the various Experts and Teams.
We are constantly inspected by the Regulatory bodies of all the Countries where we market our products. Olon sites are inspected on regular basis by the local Regulatory Agency, AIFA. Since November l, 2017 the EU-FDA mutual recognition agreement (MRA) of GMP inspections, including Italy, has come into force: the MRA allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders.
FDA will continue to perform some inspections in foreign countries but FDA expects to perform fewer routine surveillance inspections in countries like Italy, having a capable inspectorate.
Quality Management
REGULATORY INSPECTIONS
Our facilities are regularly inspected by the most important national and foreign medicine agencies: FDA – Food and Drug Administration (USA), AIFA — Agenzia Italiana del Farmaco (Italy) AEMPS Agencia Espanola de Medicamentos y productos sanitarios (Spain), Russian Health Authority, PEBC – Pharmacy Examining Board o COFEPRIS — Comisiôn Federal para la t Protecciôn contra Riesgos Sanitarios (Mexico),TGA — Therapeutic Goods Administration (Australia), PMDA Pharmaceuticals and Medical Devices Agency (Japan), KFDA – Ministry of Food and Drug Safety (Korea), ANVISA — Agency Nacional de Vigilancia Sanitdria (Brazil), WHO — World Health Organization.
